BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 2120188 · Received June 6, 2011

    Report

    Report Number
    3007566237-2011-04031
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P48001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS: MODEL NUMBER: 3776, SERIAL NUMBER: UNK. THE #6 AND 7 CONDUCTORS ON THE 3776 LEAD WERE BROKEN AT THE PROXIMAL EDGE OF THE #5 CONNECTOR SLEEVE. CONTINUITY WAS ACCEPTABLE ON #0-5. MODEL NUMBER: 37081, (B)(4). THE EXTENSION WAS FUNCTIONALLY OK. CONTINUITY WAS ACCEPTABLE- NO SHORTS. NO VISUAL ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE LEAD WAS IMPLANTED FOR A TRIAL, TEST STIMULATION HAD BEEN TRIED AT THE HOSPITAL AND WAS FINE. THEY WERE UNABLE TO USE THE SELECTED ELECTRODE, SO THE HEALTHCARE PROVIDER (HCP) CHANGED THE ELECTRODE (LEAD). THE HCP INDICATED THAT THE EVENT HAPPENED AFTER AN EXTERNAL CABLE WAS PULLED OUT ACCIDENTALLY AND THE ADAPTER CAME OFF. THE TEST STIMULATION WAS CONTINUED. THERE WAS NO HEALTH HAZARD TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL NEUROSTIMULATOR LGW MEDTRONIC NEUROMODULATION ENS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB090024V| LEAD: MODEL 3776, LOT# UNK| EXPLANTED: